SURVIVAL AND FUNCTIONALITY EVALUATION IN VITRO IN CRYOPRESERVED PLATELETS
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 281
- Locations
- 2
- Primary Endpoint
- survival of cryopreserved platelets greater than 28 days
Study Overview
Brief Summary
Platelets correspond to one of the most widely used blood components in transfusion medicine, given their importance in the prevention of bleeding disorders in patients with multifactorial thrombocytopenia and non-immunological etiology, as well as in the management of traumatic or blood-related bleeding. surgical treatments. Given its wide margin of use and the constant demand for it for use within the different management schemes and procedures associated with the medical act, it is the objective of both hemotherapy services and blood banks and blood products to have availability component constant to meet such requirements. The main problem of this resource is its short useful life (5 to 7 days) which limits its availability, especially in the Latin American context where the production of blood components as well as the resources allocated for this purpose by state entities to blood banks are generally limited. Cryopreservation at -80 ° C using Dimethylsulfoxide as a preservative solution is a technique used since the 1950s to prolong platelet survival, the improvement of which has been remarkable in recent years, thus constituting an alternative for the resolution of this problem.
Detailed Description
HYPOTHESIS: Through cryopreservation it is possible to prolong the survival time of platelets up to 4 times, compared to those preserved under the conventional method, maintaining a viability equal to or greater than 50%.
There is a direct relationship between survival time, viability and functionality of cryopreserved platelets depending on the model of cryoprotective solution used.
PRIMARY OUTCOME: survival of cryopreserved platelets greater than 28 days SECUNDARY OUTCOME: viability of cryopreserved platelets greater than 50%
INCLUSION CRITERIA: Concentrates from donors over 18 years of age who meet the requirements established by law 22990 (Of Argentine Republic) for donating blood and blood components will be included in this study, from whom a number of platelets greater than or equal to 3 x10 E11 can be collected.
EXCLUSION CRITERIA: Platelet concentrates that present any of the following characteristics will be excluded from the investigation:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
Cryopreserved samples will be labeled with a code unknown to the researcher and those who process the sample in the laboratory.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Concentrates from donors over 18 years of age who meet the requirements established by law 22990 for donating blood and blood components will be included in this study, from whom a number of platelets greater than or equal to 3 x10 E11 can be collected
Exclusion Criteria
- •Platelet concentrates that present any of the following characteristics will be excluded from the investigation:
- •Concentrates that have not met all of the standards required for use in humans or that at the time of the study more than 24 hours have passed since they were obtained.
Arms & Interventions
SURVIVAL AND FUNCTIONALITY INVITRO IN CRYOPRESERVED PLATELETS
Platelet concentrates will be administered 3 alternatives of cryopreservative solution: 5% dimethylsulfoxide (solution 1), 5% dimethylsulfoxide plus 160 mg of 5% dextrose (solution 2) and 5% dimethylsulfoxide plus 2% albumine (solution 3 ). They will then be frozen at -80 ° C and their survival and functionality will be subsequently evaluated in vitro.
Intervention: platelet cryopreservation (Other)
Outcomes
Primary Outcomes
survival of cryopreserved platelets greater than 28 days
Time Frame: Between 1 and 3 months
Secondary Outcomes
- viability of cryopreserved platelets greater than 50%(Between 1 and 3 months)
Investigators
JHON ALEXANDER AVILA RUEDA
Specialist in Internal Medicine an Hematology
HOSPITAL BRITANICO DE BUENOS AIRES